Special Investigation (All Case Survey) in Patients With Juvenile Idiopathic Arthritis

Completed

• Conditions: Arthritis, Juvenile Rheumatoid

• Registration Number: NCT01412021
• Lead Sponsor: AbbVie

Brief Summary

This study of Humira will be conducted to clarify the following with regard to the treatment of juvenile idiopathic arthritis affecting multiple joints with this drug:

* Unknown adverse drug reactions (especially important adverse drug reactions)

* Incidence and conditions of occurrence of adverse reactions in the clinical setting

* Factors that may affect the safety and effectiveness of Humira

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-01
• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-05
• Study First Posted: 2011-08-08
• Primary Completion: 2018-04-02
• Study Completion: 2018-04-02
• Status Verified: 2019-01
• Results First Submitted: 2019-03-27
• Results First Submitted QC: 2019-06-24
• Last Update Submitted: 2019-06-24
• Results First Posted: 2019-08-08
• Last Update Posted: 2019-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

• All patients with Juvenile idiopathic arthritis who are not responding well to conventional therapy and receive Humira will be enrolled in the survey

Exclusion Criteria

• Contraindications according to the Package Insert
• Patients who have serious infections
• Patients who have tuberculosis
• Patients with a history of hypersensitivity to any ingredient of Humira
• Patients who have demyelinating disease or with a history of demyelinating disease
• Patients who have congestive cardiac failure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change From Baseline in DAS28-4/CRP at Week 8	Baseline, Week 8	The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Change From Baseline in DAS28-4/CRP at Week 12	Baseline, Week 12	The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Change From Baseline in DAS28-4/ESR at Week 24	Baseline, Week 24	The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Change From Baseline in DAS28-4/CRP at Week 4	Baseline, Week 4	The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Change From Baseline in Serum MMP3 Level at Week 4	Baseline, Week 4
Change From Baseline in DAS28-4/ESR at Week 12	Baseline, Week 12	The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Change From Baseline in DAS28-4/ESR at Week 4	Baseline, Week 4	The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Change From Baseline in DAS28-4/ESR at Week 8	Baseline, Week 8	The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Change From Baseline in DAS28-4/ESR at Week 16	Baseline, Week 16	The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Change From Baseline in DAS28-4/CRP at Week 16	Baseline, Week 16	The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Change From Baseline in DAS28-4/CRP at Week 24	Baseline, Week 24	The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Change From Baseline in Serum MMP3 Level at Week 8	Baseline, Week 8
Change From Baseline in Serum MMP3 Level at Week 12	Baseline, Week 12
Change From Baseline in Serum MMP3 Level at Week 16	Baseline, Week 16
Change From Baseline in Serum MMP3 Level at Week 24	Baseline, Week 24
Change From Baseline in Physician Global Assessment (VAS) at Week 4	Baseline, Week 4	A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Change From Baseline in Physician Global Assessment (VAS) at Week 8	Baseline, Week 8	A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Change From Baseline in Physician Global Assessment (VAS) at Week 12	Baseline, Week 12	A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Change From Baseline in Physician Global Assessment (VAS) at Week 16	Baseline, Week 16	A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Change From Baseline in Physician Global Assessment (VAS) at Week 24	Baseline, Week 24	A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Change From Baseline in Anti-Cyclic Citrullinated Peptide Antibodies at Week 24	Baseline, Week 24
Change From Baseline in Height at Week 4	Baseline, Week 4
Change From Baseline in Height at Week 8	Baseline, Week 8
Change From Baseline in Height at Week 12	Baseline, Week 12
Change From Baseline in Height at Week 16	Baseline, Week 16
Change From Baseline in Height at Week 24	Baseline, Week 24
Change From Baseline in Weight at Week 4	Baseline, Week 4
Change From Baseline in Weight at Week 8	Baseline, Week 8
Change From Baseline in Weight at Week 12	Baseline, Week 12
Change From Baseline in Weight at Week 16	Baseline, Week 16
Change From Baseline in Weight at Week 24	Baseline, Week 24